Preventing the Mad Scramble Before a Pharmacy Compliance Audit

Regardless of your pharmacy role, you have likely been involved in a regulatory survey or inspection at some point during your career. With that assumption in mind, think back on the surveys you have been involved in and recall the mad scramble that ensued to verify that all things were in order immediately prior to the inspection.

There is no cause for embarrassment because this exact scenario has occurred countless times to most pharmacists, regardless of practice location. However, as the leader of the Pharmacy Compliance Program at Novant Health, a not-for-profit integrated health-system that serves patients across North Carolina, I needed a way to feel confident about our compliance readiness and for that confidence to extend beyond survey days. It was this need that drove the creation of the first layer of our pharmacy compliance program, the self-audit process. 

Self-Audit Process

Our self-audit process is a way for onsite frontline pharmacy leaders and team members to self-assess compliance before an external surveyor enters their pharmacy to inspect medication use processes. The current version of our self-audit process was created in 2019.

The timing was fortuitous because shortly thereafter, the COVID-19 pandemic forced our health system, like many others, to hasten onboarding processes and abbreviate training periods, as well as prevent non-essential workers from entering patient care areas for non-critical needs, such as compliance inspections.

During this time, the self-audit process was essential in supplementing training and oversite of our compliance expectations. The process offered reassurance to our compliance team and senior leaders from afar at a time when circumstances prevented us from being close.

Today, the process continues to instill confidence as it serves as a guide and check-and-balance that our onsite leaders are maintaining standards between internal and external compliance inspections. Other benefits include offering frontline leaders and team members the opportunity to collaborate with our compliance team and senior leaders to improve processes.

Audit Tool

Our audit tool consists of more than 200 “Yes/No” regulatory, accreditation, and policy-related questions grouped by categories, i.e., main pharmacy, medication storage, patient care unit review, controlled substances, etc (FIGURE 1). The questions are phrased so that the appropriate response is “Yes,” and a score is calculated for each category by summing the “Yes” answers over the total questions in the category.

So, for example, if there are 10 questions in a category and the frontline pharmacy leader answers 9 questions “Yes,” then the leader scores 90% for the category. Each question is linked to a supporting regulatory rule, accreditation standard, or internal policy. This detail becomes important as team members link specific tasks with the reasonsto support compliance, thus, helping to improve buy-in.

The self-audit process is based on the honor system. The frontline leader is simply reviewing their area; self-assessing practices and identifying opportunities.

At the end of the process, the frontline leader shares their score with our system-level compliance team, and we report the score to senior leaders within the department. The compliance team is also responsible for helping frontline leaders develop and follow-up on any corrective action plans that are usually due 60-days post audit.

Gaining Buy-In

So, what can you do if you are interested in creating your own self-audit process? Start by gaining buy-in. Communicate the purpose, picture, and plan for the self-audit process and work with your frontline pharmacy leaders and team members to outline their part in those audits.

The audits create an additional lift for end-users, so it is important that they understand the why behind them and remain engaged in the process enough to produce meaningful results.

Staying Engaged

To maintain engagement, first celebrate successes. We attribute a large part of our stress-free external surveys to the confidence we have in our self-audit process. Through the self-audit process, team members know that opportunities have been identified and addressed before an external survey.

Next, remain consistent. Our leaders must complete a self-audit survey every 2 months, each time assessing questions in a different category so that all questions are reviewed at least once per year.

Third, make self-audits a priority. Despite the challenges COVID-19 brought to health systems, our corporate compliance team faithfully scheduled self-audits and frontline pharmacy leaders and team members consistently completed them.

Finally, share and publicize the results of your program. If senior leaders and external stakeholders are aware of your self-audit plan, they come to expect results, which makes it difficult to not produce them.

Conclusion

The compliance self-audit process at Novant Health yields several benefits. Among them, the process provides training and oversite for frontline leaders, fosters open dialogue and collaboration between frontline team members and compliance teams, and fuels a culture of continual compliance readiness. All of which help replace the mad scramble before an external audit with confidence and peace of mind for everyone involved.

About the Author

Sacha Pollard Deloney, PharmD, MBA, System Pharmacy Director, Safety, Quality, and Educational Programs, Novant Health Pharmacy Administration.